<TITLE> <STUDY NUMBER> ADDENDUM TO THE CONSENT FOR ALL PARTICIPANTS As indicated in the initial Informed Consent, all participants will be informed of any changes in the research protocol during the course of the trial. This study now includes <CHANGES>. **************************************************************************************************** I was given the opportunity to ask questions about this change and was given sufficient time to consider my continued participation. I have received a copy of this addendum to the consent and agree to continue to participate. Name of Participant (please print) Participant’s Signature Date Signature of Person Conducting the Informed Consent Discussion Date